Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9614673

FEI Number

3003559576

Entity Name

HITACHI HIGH-TECH CORP., NAKA DIVISION

City/State/Country

Hitachinaka-shi Ibaraki, JP

Establishment Address

882 ICHIGE, Hitachinaka-shi Ibaraki 312-8504, JP

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

HITACHI HIGH-TECH CORP. (Owner Number: 9049564)

Owner / Operator Contact Address

1-17-1 Toranomon,, --, Minato-ku, JP-13 105-6409, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

cobas pro integrated solutions Ionify iRapidC cobas i Ionify iHPLC cobas i Ionify iRapidB cobas i cobas pure integrated solutions CCM Vertical Elevator Unit CCM Vertical Overhead Conveyor Unit (1m) Modular Pre-Analytics cobas 8100 automated workflow series CONVEYOR 3 Unit Modular Connection Unit Linear Buffer Unit OUTPUT UNIT Cobas 6000 Connection Unit Add-On Buffer Unit CCM Backend Connection Unit CCM Vertical Turntable Unit Cobas 8000 Connection Unit CCM Vertical Power Box Unit CONVEYOR 1 Unit CCM Address Extension Unit Power Supply Unit CONVEYOR 2 Unit CCM Bidirectional Interface Turn Unit HST Connection Unit CCM cobas c513 Connection Unit CONVEYOR 4 Unit c311 cobas 6000 Series System (c501 and e601 Module) Clinical Laboratory Automation System (CLAS) Dummy HPLC Cartridge Dummy Rapid Cartridge cobas e 801 immunoassay Analyzer ELECSYS 2010 ANALYZER e411 MODULAR E cobas c 513 Analyzer cobas i 601 cobas i 601 SBL cobas pro i 601 BL cobas 8000 Modular Analyzer Series (c502, c701, c702, e602 and ISE Module)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CFR	Hexokinase, Glucose	Clinical Chemistry	Class 2	862.1345	2019-08-19
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2019-08-19
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2019-08-19
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2019-08-19
DPM	Columns, Liquid Chromatography	Clinical Chemistry	Class 1	862.2260	2025-07-02
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2022-09-25
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2022-09-25
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2022-09-25
CFR	Hexokinase, Glucose	Clinical Chemistry	Class 2	862.1345	2022-09-25
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2022-09-25
JQP	Calculator/Data Processing Module, For Clinical Use	Clinical Chemistry	Class 1	862.2100	2014-11-24
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2013-03-11
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2013-03-11
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2013-03-11
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2013-03-11
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2014-11-27
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2017-06-02
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2017-06-02
PCA	Dna Genetic Analyzer	Clinical Chemistry	Class 2	862.2570	2013-03-13
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2014-11-04
PCA	Dna Genetic Analyzer	Clinical Chemistry	Class 2	862.2570	2020-09-24
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2017-01-16
PDJ	Hemoglobin A1c Test System	Clinical Chemistry	Class 2	862.1373	2017-01-16
DOP	Mass Spectrometer, Clinical Use	Clinical Chemistry	Class 1	862.2860	2025-07-02
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2013-03-06
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2013-03-06
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2013-03-06
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2013-03-06

Official Correspondent

No official correspondent registered.

US Agent Details

Naomichi Kawasaki Email: naomichi.kawasaki.wv@hitachi-hightech.com Phone: (925) 5586331

Related Public Records

Same Entity

HITACHI HIGH-TECH CORP.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3014840402	Hitachi High-Tech Corp., Omuta Center	Omuta-shi Fukuoka, JP
9610865	HITACHI HIGH-TECH CORP., Ome Works	Ome-Shi Tokyo, JP
1000162206	HITACHI HIGH-TECH CORP., KASHIWANOHA	KASHIWA-SHI Chiba, JP
3031570369	HITACHI HIGH-TECH CORP., Musashimurayama Center	Musashimurayama Tokyo, JP

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K761345	J.T. Baker Chemical Co.	GLUCO-HEX TM REAGENT KIT	1977-01-05
K771464	Instrumentation Laboratory CO	MULTISTAT III GLUCOSE TEST	1977-09-02
K872302	Ciba Corning Diagnostics Corp.	MODEL 550 EXPRESS CLINICAL CHEMISTRY ANALYZER	1987-09-08
K850376	Terumo Medical Corp.	TERUMO SENSIBEAD EIA TSH KIT	1985-03-04
K843395	Hybritech, Inc.	ENCORE TSH REAGENT	1984-10-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-06	Abbott Laboratories, Inc	1	ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00.
Z-0008-2024	Ortho-Clinical Diagnostics, Inc.	1	Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry System (Refurbished) (Product Code 6801890), VITROS 3600 Immunodiagnostic System (Product Code 6802783), VITROS 3600 Immunodiagnostic System (Refurbished) (Product Code 6802914), VITROS 4600 Chemistry System (Product Code 6802445), VITROS 4600 Chemistry System (Refurbished) (Product Code 6900440), VITROS 5600 Integrated System (Product Code 6802413), VITROS 5600 Integrated System (Refurbished) (Product Code 6802915), VITROS XT 3400 Chemistry System (Product Code 6844458), and VITROS XT 7600 Integrated System (Product Code 6844461)
Z-0009-06	Beckman Coulter Inc	1	Synchron LX Systems Version 4.5 Operating Software
Z-0010-06	Abbott Laboratories, Inc	1	ARCHITECT c8000 Analyzer System Processing Module, a fully automated, random access, clinical chemistry analyzer which utilizes spectrophotometry (monochromatic and bichromatic modes of measurement) for photometric based determinations.
Z-0010-2019	Radiometer America Inc	1	ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Analyzer is a portable, automated Analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. It is intended for use in a laboratory environment, near patient or point-of-care setting.

Similar Registrations

Registration Number	Establishment Name	Location
1616487	STANBIO LABORATORY	Boerne, TX, US
3003795116	ROCHE DIAGNOSTICS INTERNATIONAL LTD.	ROTKREUZ Zug, CH
3006198300	Diamond Diagnostics Inc.	Budapest, HU
9610529	ROCHE DIAGNOSTICS GMBH	PENZBERG Bavaria, DE
3000148879	HORIBA ABX SAS	MONTPELLIER Herault, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9614673. Last updated year: 2026. Please use registration number 9614673 when referencing this establishment in official correspondence.